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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K252048
Device Name 808nm semiconductor laser hair removal machine
Applicant
Xi'An Taibo Electronic Technology Co., Ltd.
3rd Floor, #1 Factory Bldg., #1787, Caotan 10 Rd.
Economic And Technological Development Zone
Xi'An,  CN
Applicant Contact Shuai Wang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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